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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

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One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

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Canada Halts Inquiry Into Janssen’s Anti-Competitive Conduct

Canada’s Competition Bureau on Wednesday discontinued its investigation into allegations that Johnson & Johnson subsidiary Janssen inhibited the entry of biosimilars that compete with its blockbuster Remicade (infliximab).

The Bureau said that although it confirmed that Janssen has engaged in, and continues to engage in, conduct that could raise concerns, there was not adequate evidence “that this conduct was likely to substantially lessen or prevent competition.”

Similar to a lawsuit filed in the US by Pfizer, which focuses on Janssen’s exclusionary tactics, the Canadian inquiry centered around whether Janssen was engaging in practices that were predatory (i.e., “deterred entry or expansion through below-cost pricing”) and exclusionary (i.e., “raised the costs of its competitors and thus made them less effective).

Analysis

The alleged conduct under inquiry in Canada involved Janssen supplying hospitals with Remicade for one cent per vial, providing free Remicade to those without insurance and like in the US, entering into contracts with hospitals and public and private insurers that require or induce them to favor Remicade over its biosimilars, in addition to exclusive contracts with infusion clinics that prohibit them from infusing Remicade biosimilars.

“The Bureau's inquiry confirmed that Janssen was engaging in many of the alleged practices. In particular, market participants confirmed that Janssen was supplying many hospitals throughout Canada with Remicade for 1 cent per vial, providing free Remicade to a large number of patients without insurance coverage for the drug, and had negotiated exclusivity with certain third-party infusion clinic networks, which prevent them from administering patients with certain other biologic and biosimilar drugs, including biosimilars to Remicade,” the Bureau said.

But the Bureau’s review also found that Janssen does not have contracts with hospitals and public and private insurers that require or induce them to favor Remicade over its biosimilars.

“Instead, these contracts, which have only been negotiated with certain private and public insurers (i.e., not with hospitals), have resulted in these insurers not implementing policies that would result in biosimilar drugs being reimbursed on more favourable terms than Remicade,” the Bureau added.

In terms of whether Janssen’s practices were predatory and exclusionary, the Bureau said it “did not find credible evidence that Janssen's low pricing strategy was sufficiently widespread that it was likely to eliminate, discipline or deter entry by one or more competitors, so as to substantially prevent or lessen competition in the relevant market.”

And while Janssen's low prices may have shifted demand to Remicade, the Bureau also “did not find that the practice was likely to induce competitors to exit the market or otherwise substantially affect competition at this time.”

Similarly, the Bureau said it “did not find adequate evidence that Janssen's contracts with private and public insurers resulted in higher costs for infliximab. This is because Janssen negotiated these contracts by offering increasing rebates to public and private insurers following the entry of Inflectra and Renflexis, which significantly reduce Remicade's net price.”

Meanwhile, the Bureau said it will continue to monitor the biologic and biosimilar industries to identify other types of conduct by companies that sell reference biologics that could raise concerns.